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Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active …

Harmonised standards - Public Health

    https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en
    The publications in the OJEU of references of harmonised standards under the medical devices regulations are available: For Regulation (EU) 2017/745 Search for …

New publication of Harmonised standards under the medical …

    https://health.ec.europa.eu/latest-updates/new-publication-harmonised-standards-under-medical-devices-regulations-2022-05-17_en
    New publication of Harmonised standards under the medical devices Regulations News announcement17 May 2022Directorate-General for Health and Food …

Medical devices - Internal Market, Industry, Entrepreneurship and …

    https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_en
    Guidelines related to medical devices regulations; European Commission contact point: Directorate-General for Health and Food Safety Medical devices Email Webpage on …

The European Union Medical Device Regulation – …

    https://eumdr.com/
    The European Union Medical Device Regulation – Regulation (EU) 2017/745 (EU MDR) Click the link below to view the latest information from the European Commission on the …

Guidance - MDCG endorsed documents and other guidance

    https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
    European Medical Device Nomenclature (EMDN) Implant cards In-house devices Authorised Representatives, Importers, Distributors In Vitro Diagnostic medical devices …

Medical Devices - Sector - Public Health

    https://health.ec.europa.eu/medical-devices-sector_en
    The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively... New …

Ultimate List of ISO Standards for Medical Devices

    https://www.greenlight.guru/blog/iso-standards
    Oct 5, 2022

Quick Guide to Medical Device Standards: ISO …

    https://www.rqmplus.com/blog/quick-guide-to-medical-device-standards-iso-standards-and-beyond
    The most current version is ISO 14971:2019, but it isn’t yet harmonized in Europe. ISO 9001, which is the standard for business quality management systems, and the most …

What EU Regulations Do Medical Device Manufacturers Need To …

    https://blog.sourceintelligence.com/eu-regulations-medical-device-manufacturers
    As a regulation, MDR harmonizes standards on medical device compliance across all member states and is mandatory for all companies that wish to sell or distribute …



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